EUROPEAN CLINICAL TRIALS DIRECTIVE

The full title of the Directive is "Directive of the European Parliament and of the Council on the approxi mat ion of the laws, regulations and administrative provisions of the Member States relating to implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use". Agreement on this Directive was reached in February 2001 and the final version was published in the "Official Journal of the European Communities" on 1 May 2001 . The directive was transposed into UK Law on 1 April 2004 and implemented on 1 May 2004.

The scope of the Directive is wide. It covers the conduct of clinical trials in the European Union on human subjects involving medicinal products. In effect, every clinical trial involving medicinal products will be covered. The Directive sets standards for protecting clinical trial subjects. It will also establish ethics committee on a legal basis and provide legal status for certain procedures. It also lays down standards for the manufacture, import and labelling of investigational medicinal products (IMPs) and provides for quality assurance of clinical trials and IMPs. To ensure compliance with these standards, Member States are required to set up inspection systems for Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). The Directive also provides for safety monitoring of patients in trials, and sets out procedures for reporting and recording adverse drug reactions. The Directive's provisions do not distinguish between commercial and non-commercial clinical trials.